Shandong Xingyu Gloves Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Shandong Xingyu Gloves Co., Ltd. makes
Shandong Xingyu Gloves Co., Ltd. manufactures disposable nitrile examination gloves in blue and white, including versions tested for use with chemotherapy drugs and fentanyl. They also produce medical face masks designed for single-use in healthcare settings.
Their products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The company is based in the US and has devices listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) Ref K233990
Regimes: 510(k) Registry: 510(k)Medical Face Mask Ref K221272
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Shandong Xingyu Gloves Co., Ltd Gaomi Shandong · CN FEI 3013451367
Frequently asked questions
How many devices does Shandong Xingyu Gloves Co., Ltd. have in the registry?
The registry currently lists 4 devices for Shandong Xingyu Gloves Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Xingyu Gloves Co., Ltd.'s devices?
Among its 4 most recently registered devices, Shandong Xingyu Gloves Co., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Shandong Xingyu Gloves Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Shandong Xingyu Gloves Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shandong Xingyu Gloves Co., Ltd. in the registry?
The most recently registered devices listed for Shandong Xingyu Gloves Co., Ltd. include Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color, Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000), Medical Face Mask and Xingyu Nitrile Powder Free Patient Examination Gloves, White color.
Which FDA establishments are linked to Shandong Xingyu Gloves Co., Ltd.?
1 FDA establishment is linked to Shandong Xingyu Gloves Co., Ltd. in the registry; they are listed on the company page.